methodology
Autogenic training (AT) is a relaxation technique that has garnered attention for its potential to reduce anxiety and improve psychological well-being. This review aimed to synthesize the findings from a diverse range of studies investigating the relationship between AT and anxiety disorder across different populations and settings.
A comprehensive review of 162 studies, including randomised controlled trials (RCTs), non-randomized controlled trials (N-RCTs), surveys, and meta-analysis, was conducted and 29 studies were selected. Participants in the studies were patients with:
- cancer,
- bulimia nervosa,
- stroke,
- coronary angioplasty,
Others were nursing students, healthy volunteers, athletes, etc.
Anxiety levels were measured before and after the AT intervention using a variety of anxiety assessment scales, including the State Trait Anxiety Inventory (STAI) and the Hospital Anxiety and Depression Scale (HADS). The formats, duration, and delivery of the interventions varied, with some studies utilising guided sessions by professionals and other self-administered practises.
The combined findings of these studies revealed consistent trends in the beneficial effects of AT on anxiety reduction. AT was found to be effective in reducing anxiety symptoms across a wide range of populations and settings. Following AT interventions, participants reported reduced anxiety, improved mood states, and improved coping mechanisms. AT was found to be superior to no treatment or a comparable intervention in a number of cases.
The authors conclused that the body of evidence supports autogenic training as a non-pharmacological approach to reducing anxiety and improving psychological well-being. Despite differences in methodology and participant profiles, the studies show that AT has a positive impact on a wide range of populations. The findings merit further investigation and highlight AT’s potential contribution to anxiety management strategies.
I was taught AT many years ago and have practised it occasionally ever since. I have also co-authored several papers of AT that showed encouraging results, e.g.:
- Autogenic training for tension type headaches: a systematic review of controlled trials. Complement Ther Med. 2006 Jun;14(2):144-50.
- Autogenic training for stress and anxiety: a systematic review. Complement Ther Med. 2000 Jun;8(2):106-10.
- Autogenic training to reduce anxiety in nursing students: randomized controlled trial. Kanji N, White A, Ernst E.J Adv Nurs. 2006 Mar;53(6):729-35.
- Autogenic training to manage symptomology in women with chest pain and normal coronary arteries. Menopause. 2009 Jan-Feb;16(1):60-5.
- Autogenic training reduces anxiety after coronary angioplasty: a randomized clinical trial. Am Heart J. 2004 Mar;147(3)
Thus, I feel that the conclusions of this review might be correct.
Several further recent papers seem to support the notion that AT is a treatment worth trying, e.g.:
- A review concluded that as an add-on intervention psychotherapy technique with beneficial outcome on psychophysiological functioning, AT represents a promising avenue towards expanding research findings of brain-body links beyond the current limits of the prevention and clinical management of number of mental disorders.
- A clinical trial showed that AT seems to improve sleep quality and could improve some dimensions of quality of life and other symptoms among people living with HIV. Further studies are needed to confirm these results.
Why then AT is not better studied and more popular? A short paragraph of my next book (to be published in about 6 months) on the inventors of so-called alternative medicines (SCAMs), including the German psychiatry professor Johannes Schulz (1884-1970), inventor of AT, might give you a clue:
Schultz supported the euthanasia program of the Nazis, i.e. the extermination of disabled and other people considered ‘unworthy of living’ during the Third Reich. He passed death sentences on “hysterical women” through his diagnoses. In 1933, Schultz began research on a guide-book on sexual education in which he focused on homosexuality and explored the topics of sterilization and euthanasia. In 1935, he published an essay about the psychological consequences of sterilization and castration among men; in it he supported compulsory sterilization of men in order to eliminate hereditary illnesses. With a diagnostic scheme developed by him in 1940, Schulz advocated the execution of mentally ill patients by stating: “I personally have to align myself with Mr. Hoche […], by recalling the ‘annihilation of life unworthy of life’ and by raising the hope that the madhouses will soon become emptied and remodelled according to this principle.” Schultz was fully aware of the consequences of his diagnostic assessment and even used the term “death sentence in the form of a diagnosis”.
I came across this evidence only years after having published my papers on AT. Would I have developed an interest in AT, if I had known about Schulz’s Nazi past? Probably not.
This systematic review aimed to assess the impact of Tai Chi on individuals with essential hypertension and to compare the effects of Tai Chi with other therapies. The researchers conducted a systematic literature search of the Medline, Scholar, Elsevier, Wiley Online Library, Chinese Academic Journal (CNKI) and Wanfang databases from January 2003 to August 2023. Using the methods of the Cochrane Collaboration Handbook, a meta-analysis was conducted to assess the collective impact of Tai Chi exercise in controlling hypertension. The primary outcomes measured included blood pressure and nitric oxide levels.
A total of 32 RCTs were included. The participants consisted of adults with an average age of 57.1 years who had hypertension (mean ± standard deviation systolic blood pressure at 148.2 ± 12.1 mmHg and diastolic blood pressure at 89.2 ± 8.3 mmHg). Individuals who practiced Tai Chi experienced reductions in systolic blood pressure of 10.6 mmHg, diastolic blood pressure of 4.7 mmHg and an increase in nitric oxide levels.
The authors concluded that Tai Chi can be a viable lifestyle intervention for managing hypertension. Greater promotion of Tai Chi by medical professionals could extend these benefits to a larger patient population.
Tai Chi allegedly incorporates principles rooted in the Yin and Yang theory, Chinese medicine meridians and breathing techniques, and creates a unique form of exercise characterized by its inward focus, continuous flow, the balance of strength and gentleness, and alternation between fast and slow movements. What sets Tai Chi apart from other forms of excercise is the requirement for mindful guidance during practice. This aspect may, according to the authors, be the reason why Tai Chi also outperforms general aerobic exercise in managing hypertension.
I can well imagine that any form of relaxation reduces blood pressure. What I find hard to believe is that Tai Chi is better than any other relaxing SCAMs. The 32 RCTs included in this new review fail to impress me because they are all from China, and – as we have often mentioned before – studies from China are to be taken with a pinch of salt.
Yet, the subject is important enough, in my view, to merit a few rigorous trials conducted by independent researchers. Until such data are available, I think, I prefer to rely on our own systematic review which conculded that the evidence for tai chi in reducing blood pressure … is limited. Whether tai chi has benefits over exercise is still unclear. The number of trials and the total sample size are too small to draw any firm conclusions.
So-called alternative medicine (SCAM) interventions are growing in popularity and are even advocated as treatments for long COVID symptoms. However, comprehensive analysis of current evidence in this setting is still lacking. This study aims to review existing published studies on the use of SCAM interventions for patients experiencing long COVID through a systematic review of randomized controlled trials (RCTs).
A comprehensive electronic literature search was performed in multiple databases and clinical trial registries from September 2019 to January 2023. RCTs evaluating efficacy and safety of SCAM for long COVID were included. Methodological quality of each included trial
was appraised with the Cochrane ‘risk of bias’ tool. A qualitative analysis was conducted due to heterogeneity of included studies.
A total of 14 RCTs with 1195 participants were included in this review. Study findings demonstrated that SCAM interventions could benefit patients with long COVID, especially those suffering from
- neuropsychiatric disorders,
- olfactory dysfunction,
- cognitive impairment,
- fatigue,
- breathlessness,
- mild-to-moderate lung fibrosis.
The main interventions reported were:
- self-administered transcutaneous auricular vagus nerve stimulation,
- neuro-meditation,
- dietary supplements,
- olfactory training,
- aromatherapy,
- inspiratory muscle training,
- concurrent training,
- online breathing programs,
- online well-being programs.
The authors concluded that SCAM interventions may be effective, safe, and acceptable to patients with symptoms of long COVID. However, the findings from this systematic review should be interpreted with caution due to various methodological limitations. More rigorous trials focused on CAM for long COVID are warranted in the future.
Such wishy-washy conclusions seem to be popular in the fantasy land of SCAM. Yet, they are, in my view, most ojectionable because:
- they tell us nothing of value;
- that something “MAY BE EFFECTIVE” has been known before and cannot be the result of but is the reason for a systematic review;
- a review of 14 RCTs of almost as many interventions cannot possibly tell us anything about the SAFETY of these treatments;
- it also does not provide evidence of effectiveness and merely indicates a lack of independent replications;
- if the abstract mentions an assessment of the study rigor, one expects that it also informs us about this important aspect.
Once we do come around looking at the methodological quality of the primary studies we realize that it is mostly miserable. This means that the conclusions of the review are not just irritating but plainly misleading. Responsible researchers should have concluded along the following lines:
The quantity and the quality of the evidence are both low. Therefore, the effectiveness and safety of SCAM interventions for long COVID remains unproven.
PS
This project was financially supported by The HEAD Foundation, Singapore and in part by the grant from the NIH R61 AT01218.
Shame on the authors, journal editors, peer-reviewers, and funders of this dangerous nonsense!
Many of you will be familiar with the ‘ALTERNATIVE MEDICINE HALL OF FAME’. It is my creation and meant to honour reserchers who have dedicated much of their professional career to investigating a form of so-called alternative medicine (SCAM) without ever publishing negative conclusions about it. Obviously, if anyone studies any therapy, he/she will occasionally produce a negative finding. This would be the case, even if he/she tests an effective treatment. However, if the treatment in question comes from the realm of SCAM, one would expect negative results fairly regularly. No therapy works well under all conditions, and to the best of my knowledge, no SCAM is a panacea!
This is why researchers who defy this inevitability are remarkable. If someone tests a treatment that is at best dubious and at worst bogus, we are bound to see some studies that are not positive. He/she would thus have a high or normal ‘TRUSTWORTHINESS INDEX‘ (another creation of mine which, I think, is fairly self-explanatory). Conversely, any researcher who does manage to publish nothing but positive results of a SCAM is bound to have a very low ‘TRUSTWORTHINESS INDEX‘. In other words, these people are special, so much so that I decided to honour such ‘geniuses’ by admitting them to my ALTERNATIVE MEDICINE OF FAME.
So far, this elite group of people comprises the following individuals:
- Helge Franke (osteopathy, Germany)
- Tery Oleson (acupressure , US)
- Jorge Vas (acupuncture, Spain)
- Wane Jonas (homeopathy, US)
- Harald Walach (various SCAMs, Germany)
- Andreas Michalsen ( various SCAMs, Germany)
- Jennifer Jacobs (homeopath, US)
- Jenise Pellow (homeopath, South Africa)
- Adrian White (acupuncturist, UK)
- Michael Frass (homeopath, Austria)
- Jens Behnke (research officer, Germany)
- John Weeks (editor of JCAM, US)
- Deepak Chopra (entrepreneur, US)
- Cheryl Hawk (chiropractor, US)
- David Peters (osteopathy, homeopathy, UK)
- Nicola Robinson (TCM, UK)
- Peter Fisher (homeopathy, UK)
- Simon Mills (herbal medicine, UK)
- Gustav Dobos (various SCAMs, Germany)
- Claudia Witt (homeopathy, Germany/Switzerland)
- George Lewith (acupuncture, UK)
- John Licciardone (osteopathy, US)
You will notice that the group does not yet contain a representative of anthroposophic medicine. Today, I intend to rectify this oversight by admitting Helmut Kiene (1952-). He has published plenty of studies and reviews on his pet subject; here are the ones that I found on Medline:
- Anthroposophic therapies in chronic disease: the Anthroposophic Medicine Outcomes Study (AMOS). Eur J Med Res. 2004 Jul 30;9(7):351-60.
- Anthroposophic medical therapy in chronic disease: a four-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.BMC Complement Altern Med. 2007 Apr 23;7:10. doi: 10.1186/1472-6882-7-10.
- Anthroposophic art therapy in chronic disease: a four-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.Explore (NY). 2007 Jul-Aug;3(4):365-71. doi: 10.1016/j.explore.2007.04.008.
- Rhythmical massage therapy in chronic disease: a 4-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.J Altern Complement Med. 2007 Jul-Aug;13(6):635-42. doi: 10.1089/acm.2006.6345
- Anthroposophic vs. conventional therapy for chronic low back pain: a prospective comparative study. Hamre HJ, Witt CM, Glockmann A, Wegscheider K, Ziegler R, Willich SN, Kiene H.Eur J Med Res. 2007 Jul 26;12(7):302-10.
- Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research. Kienle GS, Glockmann A, Schink M, Kiene H.J Exp Clin Cancer Res. 2009 Jun 11;28(1):79. doi: 10.1186/1756-9966-28-79.
- Anthroposophic therapy for children with chronic disease: a two-year prospective cohort study in routine outpatient settings. Hamre HJ, Witt CM, Kienle GS, Meinecke C, Glockmann A, Willich SN, Kiene H.BMC Pediatr. 2009 Jun 19;9:39. doi: 10.1186/1471-2431-9-39
- Predictors of outcome after 6 and 12 months following anthroposophic therapy for adult outpatients with chronic disease: a secondary analysis from a prospective observational study. Hamre HJ, Witt CM, Kienle GS, Glockmann A, Willich SN, Kiene H.BMC Res Notes. 2010 Aug 3;3:218. doi: 10.1186/1756-0500-3-218.
- Pulpa dentis D30 for acute reversible pulpitis: A prospective cohort study in routine dental practice. Hamre HJ, Mittag I, Glockmann A, Kiene H, Tröger W.Altern Ther Health Med. 2011 Jan-Feb;17(1):16-21.
- Use and safety of anthroposophic medications for acute respiratory and ear infections: a prospective cohort study. Hamre HJ, Glockmann A, Fischer M, Riley DS, Baars E, Kiene H.
- [Clinical research on anthroposophic medicine:update of a health technology assessment report and status quo]. Kienle GS, Glockmann A, Grugel R, Hamre HJ, Kiene H.Forsch Komplementmed. 2011;18(5):269-82. doi: 10.1159/000331812. Epub 2011 Oct 4.
- Anthroposophical medicine: a systematic review of randomised clinical trials. Kienle GS, Hamre HJ, Kiene H.Wien Klin Wochenschr. 2004 Jun 30;116(11-12):407-8; author reply 408. doi: 10.1007/BF03040923.
- Eurythmy therapy in chronic disease: a four-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.BMC Public Health. 2007 Apr 23;7:61. doi: 10.1186/1471-2458-7-61.
- Long-term outcomes of anthroposophic therapy for chronic low back pain: A two-year follow-up analysis. Hamre HJ, Witt CM, Kienle GS, Glockmann A, Ziegler R, Willich SN, Kiene H.J Pain Res. 2009 Jun 25;2:75-85. doi: 10.2147/jpr.s5922.
- Health costs in anthroposophic therapy users: a two-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.BMC Health Serv Res. 2006 Jun 2;6:65. doi: 10.1186/1472-6963-6-65.
- Use and safety of anthroposophic medications in chronic disease: a 2-year prospective analysis. Hamre HJ, Witt CM, Glockmann A, Tröger W, Willich SN, Kiene H.Drug Saf. 2006;29(12):1173-89. doi: 10.2165/00002018-200629120-00008.
- Anthroposophic therapy for chronic depression: a four-year prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Willich SN, Kiene H.BMC Psychiatry. 2006 Dec 15;6:57. doi: 10.1186/1471-244X-6-57.
- Health costs in patients treated for depression, in patients with depressive symptoms treated for another chronic disorder, and in non-depressed patients: a two-year prospective cohort study in anthroposophic outpatient settings. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Kienle GS, Willich SN, Kiene H.Eur J Health Econ. 2010 Feb;11(1):77-94. doi: 10.1007/s10198-009-0203-0.
- Outcome of anthroposophic medication therapy in chronic disease: a 12-month prospective cohort study. Hamre HJ, Witt CM, Glockmann A, Ziegler R, Kienle GS, Willich SN, Kiene H.Drug Des Devel Ther. 2009 Feb 6;2:25-37.
- Clinical research in anthroposophic medicine. Hamre HJ, Kiene H, Kienle GS.Altern Ther Health Med. 2009 Nov-Dec;15(6):52-5.
- Anthroposophic therapy for attention deficit hyperactivity: a two-year prospective study in outpatients. Hamre HJ, Witt CM, Kienle GS, Meinecke C, Glockmann A, Ziegler R, Willich SN, Kiene H.Int J Gen Med. 2010 Aug 30;3:239-53. doi: 10.2147/ijgm.s11725.
- Anthroposophic therapy for asthma: A two-year prospective cohort study in routine outpatient settings. Hamre HJ, Witt CM, Kienle GS, Schnürer C, Glockmann A, Ziegler R, Willich SN, Kiene H.J Asthma Allergy. 2009 Nov 24;2:111-28.
- Anthroposophic therapy for migraine: a two-year prospective cohort study in routine outpatient settings. Hamre HJ, Witt CM, Kienle GS, Glockmann A, Ziegler R, Rivoir A, Willich SN, Kiene H.Open Neurol J. 2010;4:100-10.
- Antibiotic Use in Children with Acute Respiratory or Ear Infections: Prospective Observational Comparison of Anthroposophic and Conventional Treatment under Routine Primary Care Conditions. Hamre HJ, Glockmann A, Schwarz R, Riley DS, Baars EW, Kiene H, Kienle GS.Evid Based Complement Alternat Med. 2014;2014:243801.
- An assessment of the scientific status of anthroposophic medicine, applying criteria from the philosophy of science. Baars EW, Kiene H, Kienle GS, Heusser P, Hamre HJ.Complement Ther Med. 2018 Oct;40:145-150.
- Anthroposophic vs. conventional therapy of acute respiratory and ear infections: a prospective outcomes study. Hamre HJ, Fischer M, Heger M, Riley D, Haidvogl M, Baars E, Bristol E, Evans M, Schwarz R, Kiene H.Wien Klin Wochenschr. 2005 Apr;117(7-8):256-68. doi: 10.1007/s00508-005-0344-9.
- Long-term outcomes of anthroposophic treatment for chronic disease: a four-year follow-up analysis of 1510 patients from a prospective observational study in routine outpatient settings. Hamre HJ, Kiene H, Glockmann A, Ziegler R, Kienle GS.BMC Res Notes. 2013 Jul 13;6:269. doi: 10.1186/1756-0500-6-269
- Eurythmy Therapy in anxiety. Kienle GS, Hampton Schwab J, Murphy JB, Andersson P, Lunde G, Kiene H, Hamre HJ.Altern Ther Health Med. 2011 Jul-Aug;17(4):56-63
- Mistletoe in cancer – a systematic review on controlled clinical trials. Kienle GS, Berrino F, Büssing A, Portalupi E, Rosenzweig S, Kiene H.Eur J Med Res. 2003 Mar 27;8(3):109-19.
- Anthroposophic therapy of respiratory and ear infections. Hamre HJ, Fischer M, Heger M, Riley D, Haidvogl M, Baars E, Bristol E, Evans M, Schwarz R, Kiene H.Wien Klin Wochenschr. 2005 Jul;117(13-14):500-1. doi: 10.1007/s00508-005-0389-9
- Complementary cancer therapy: a systematic review of prospective clinical trials on anthroposophic mistletoe extracts.
Eur J Med Res. 2007 Mar 26;12(3):103-19.
- Review article: Influence of Viscum album L (European mistletoe) extracts on quality of life in cancer patients: a systematic review of controlled clinical studies. Kienle GS, Kiene H.Integr Cancer Ther. 2010 Jun;9(2):142-57.
- [Anthroposophic medicine: health technology assessment report – short version].
Forsch Komplementmed. 2006;13 Suppl 2:7-18. doi: 10.1159/000093481. Epub 2006 Jun 26.
- Bilateral Asynchronous Renal Cell Carcinoma With Lung Metastases: A Case Report of a Patient Treated Solely With High-dose Intravenous and Subcutaneous Viscum album Extract for a Second Renal Lesion. Reynel M, Villegas Y, Kiene H, Werthmann PG, Kienle GS.Anticancer Res. 2019 Oct;39(10):5597-5604. doi: 10.21873/anticanres.13754.
- Long-term survival of a patient with an inoperable thymic neuroendocrine tumor stage IIIa under sole treatment with Viscum album extract: A CARE compliant clinical case report. Reynel M, Villegas Y, Werthmann PG, Kiene H, Kienle GS.Medicine (Baltimore). 2020 Jan;99(5):e18990. doi: 10.1097/MD.0000000000018990
- Long-Term Survival of a Patient with Recurrent Dedifferentiated High-Grade Liposarcoma of the Retroperitoneum Under Adjuvant Treatment with Viscum album L. Extract: A Case Report. Reynel M, Villegas Y, Werthmann PG, Kiene H, Kienle GS.Integr Cancer Ther. 2021 Jan-Dec;20:1534735421995258. doi: 10.1177/1534735421995258.
- Intralesional and subcutaneous application of Viscum album L. (European mistletoe) extract in cervical carcinoma in situ: A CARE compliant case report. Reynel M, Villegas Y, Kiene H, Werthmann PG, Kienle GS.Medicine (Baltimore). 2018 Nov;97(48):e13420.
- High-Dose Viscum album Extract Treatment in the Prevention of Recurrent Bladder Cancer: A Retrospective Case Series.
Perm J. 2015 Fall;19(4):76-83. doi: 10.7812/TPP/15-018.
- Disappearance of an advanced adenomatous colon polyp after intratumoural injection with Viscum album (European mistletoe) extract: a case report. von Schoen-Angerer T, Goyert A, Vagedes J, Kiene H, Merckens H, Kienle GS.J Gastrointestin Liver Dis. 2014 Dec;23(4):449-52. doi: 10.15403/jgld.2014.1121.234.acpy.
- Viscum Album in the Treatment of a Girl With Refractory Childhood Absence Epilepsy. von Schoen-Angerer T, Madeleyn R, Kienle G, Kiene H, Vagedes J.J Child Neurol. 2015 Jul;30(8):1048-52. doi: 10.1177/0883073814541473. Epub 2014 Jul 17.
- Improvement of Asthma and Gastroesophageal Reflux Disease With Oral Pulvis stomachicus cum Belladonna, a Combination of Matricaria recutita, Atropa belladonna, Bismuth, and Antimonite: A Pediatric Case Report. von Schoen-Angerer T, Madeleyn R, Kiene H, Kienle GS, Vagedes J.Glob Adv Health Med. 2016 Jan;5(1):107-11. doi: 10.7453/gahmj.2015.019. Epub 2016 Jan 1.
- Use of Iscador, an extract of European mistletoe (Viscum album), in cancer treatment: prospective nonrandomized and randomized matched-pair studies nested within a cohort study. Grossarth-Maticek R, Kiene H, Baumgartner SM, Ziegler R.Altern Ther Health Med. 2001 May-Jun;7(3):57-66, 68-72, 74-6 passim
WHAT A LIST!
It makes several things very clear to me:
- Kiene is a productive researcher
- He likes observational studies and case reports
- He dislikes the idea of rigorously testing a hypothesis
- He never publishes a negative finding about anthroposophical medicine
- He certainly deserves to be admitted to the ALTERNATIVE MEDICINE HALL OF FAME!
Welcome Helmut
This review evaluated the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and assessed whether different types of sham acupuncture are associated with different responses. Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges’g) were applied to estimate the effect size.
A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD −1.43, 95% confidence interval (CI) −1.95 to −0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD −0.49, 95% CI −0.70 to −0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI −0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.
The authors concluded that sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.
As the authors stated in their conclusion: the effect of other contextual factors cannot be ruled out. I would go much further and say that the outcomes noted here are mostly due to effects other than placebo. Obvious candidates are:
- regression towards the mean;
- natural history of the condition;
- success of patient blinding;
- social desirability.
To define the placebo effect in acupuncture trials as the change in the outcome measures from baseline to the end of treatment – as the authors of the review do – is not just naive, it is plainly wrong. I would not be surprised, if different sham acupuncture treatments have different effects. To me this would be an expected, plausible finding. But such differences just cannot be estimated in the way the authors suggest. For that, we would need an RCT in which patients are randomized to be treated in the same setting with a range of different types of sham acupuncture. The results of such a study might be revealing but I doubt that many ethics committees would be happy to grant their approval for it.
In the absence of such data, the best we can do is to design trials such that the verum is tested against a credible placebo which, for patients, is indistinguishable from the verum, while demonstrating that blinding is successful.
Since 1997, several meta-analyses (MAs) of placebo-controlled randomised efficacy trials of homoeopathy for any indication (PRETHAIs) have been published with different methods, results and conclusions. To date, a formal assessment of these MAs has not been performed. The main objective of this systematic review of MAs of PRETHAIs was to evaluate the efficacy of homoeopathic treatment.
The inclusion criteria were as follows: MAs of PRETHAIs in humans; all ages, countries, settings, publication languages; and MAs published from 1 Jan. 1990 to 30 Apr. 2023. The exclusion criteria were as follows: systematic reviews without MAs; MAs restricted to age or gender groups, specific indications, or specific homoeopathic treatments; and MAs that did not assess efficacy. We searched 8 electronic databases up to 14 Dec. 2020, with an update search in 6 databases up to 30 April 2023.
The primary outcome was the effect estimate for all included trials in each MA and after restricting the sample to trials with high methodological quality, according to predefined criteria. The risk of bias for each MA was assessed by the ROBIS (Risk Of Bias In Systematic reviews) tool. The quality of evidence was assessed by the GRADE framework. Statistical analyses were performed to determine the proportion of MAs showing a significant positive effect of homoeopathy vs. no significant difference.
Six MAs were included, covering individualised homoeopathy (I-HOM, n = 2), nonindividualised homoeopathy (NI-HOM, n = 1) and all homoeopathy types (ALL-HOM = I-HOM + NI-HOM, n = 3). The MAs comprised between 16 and 110 trials, and the included trials were published from 1943–2014. The median trial sample size ranged from 45 to 97 patients. The risk of bias (low/unclear/high) was rated as low for three MAs and high for three MAs.
Effect estimates for all trials in each MA showed a significant positive effect of homoeopathy compared to placebo (5 of 5 MAs, no data in 1 MA). Sensitivity analyses with sample restriction to high-quality trials were available from 4 MAs; the effect remained significant in 3 of the MAs (2 MAs assessed ALL-HOM, 1 MA assessed I-HOM) and was no longer significant in 1 MA (which assessed NI-HOM).
The authors concluded that the quality of evidence for positive effects of homoeopathy beyond placebo (high/moderate/low/very low) was high for I-HOM and moderate for ALL-HOM and NI-HOM. There was no support for the alternative hypothesis of no outcome difference between homoeopathy and placebo. The available MAs of PRETHAIs reveal significant positive effects of homoeopathy beyond placebo. This is in accordance with laboratory experiments showing partially replicable effects of homoeopathically potentised preparations in physico-chemical, in vitro, plant-based and animal-based test systems.
Reading this SR, I got the impression that it was designed to generate a positive result. The 6 included MAs are marginally positive (mainly due to publication bias and other artefacts) and thus very well known to fans of homeopathy. The authors of this paper must therefore have expected that combining them in a review would generate an overall positive finding.
The first question I asked myself while studying this paper was: who would want to do an SR of MAs (a most peculiar exercise); why not at least an SR of SRs which is already an unusual project but would make at least some sense. (An SR is a review that includes all studies that match a set of pre-definied criteria. A MA is a special form of SR where statistical pooling was possible.) The answer is, I fear, simple: this would not have generated a positive result: here are now dozens of SRs of homeopathy and most are not positive (as discussed regularly on this blog)
The authors themselves provide no real justification for their bizarre approach. All they tell us about it is this:
One approach is to focus on a specifc indication (e.g., depression [4], acute respiratory tract infections in children [5]) while often including open-label trials and observational studies. In this approach, data synthesis is grouped by design, thus yielding information about homoeopathy in patient care. Te opposite approach is to include all indications while restricting study designs to placebo-controlled trials and aggregating results in an MAs, thus yielding information about the specifc efects of homoeopathy beyond those of placebo. A major reason for using this approach has been the claim that ‘homoeopathy violates natural laws and thus any efect must be a placebo efect’ [6].
Since 1997, at least six MAs of placebo-controlled homoeopathy trials for any condition have been published [6–11]. These MAs have difered in their methods for trial inclusion, data synthesis and assessment of risk of bias; furthermore, their results and conclusions have been inconsistent. During this period, there have been substantial advancements in methodology and quality standards for MAs and other SRs [12–15], including SRs of SRs (also called overviews or umbrella reviews) [16–18]. To our knowledge, a formal SR of MAs of randomised placebo-controlled homoeopathy trials for any condition has not been performed. Herein, we report such an SR.
What the authors actually did is this: they knew of the 6 MA; they also knew that they arrived at cautiously positive conclusions; finally they also were aware of the fact that, obviously, the 6 MA included more or less almost the same primary studies. So, by pooling the MAs, they generated a positive result which was no longer marginally positive but strongly. Anyone looking through this strategy (which in effect multiplies the results of many primary studies by factor 6) must realize that this methods creates a false-positive impression.
My suspicion that this paper is a deliberate attempt at misleading us about the ‘efficacy’ (actually it should be effectiveness) is strengthened by further facts:
- One of the two MAs by Mathie et al excluded primary studies that reported positive findings (i.e. mine and the one by Walach et al)
- Funding: Open Access funding enabled and organized by Projekt DEAL. Funding specifcally for this SR was provided by Christophorus-Stiftung (No. 393 CST), Stiftung Marion Meyenburg (Date 24.09.2020), Dr. Hauschka Stiftung (Date 16.11.2020) and Gesellschaft für Pluralität im Gesundheitswesen (Dates 11.06.2021, 22.06.2021). General funding for IFAEMM was provided by the Software-AG Stiftung (SE-P 13544). The funders had no infuence on the writing of the protocol or on the planning, conduct and publication of this SR.
- Competing interests: In the past 3 years, HJH has received research grants from two manufacturers of anthroposophic medicinal products (Wala Heilmittel GmbH, Bad Boll/ Eckwälden, Germany; Weleda AG, Arlesheim Switzerland). Anthroposophic medicine is not based on the homoeopathic simile principle or on drug provings, but some anthroposophic medicinal products are potentized. The two manufacturers had no involvement with the present SR. Anthroposophic medicinal products were not part of the intervention in any of the trials evaluated in the MAs of this SR (Suppl. Table 15). DSR has received a development grant from Heel GmbH (manufacturer of homoeopathic products) for online training in case report writing. AG, KvA and HK declare that they have no competing interests.
- Author details: 1) Institute for Applied Epistemology and Medical Methodology at Witten/ Herdecke University (IFAEMM), Freiburg, Germany. 2) Faculty of Health, Department of Medicine, Chair of Medical Theory, Integrative and Anthroposophic Medicine, Witten/Herdecke University, Witten, Germany. 3) Maryland University of Integrative Health (MUIH), Laurel, MD, USA. 4) Homeopathic Pharmacopoeia Convention of the United States (HPCUS), Southeastern, PA, USA.
Personally, I do not find it surprising that these authors bend over backwards to publish something positive about homeopathy (such things happen in homeopathy all the time). However, I do find it astonishing that an allegedly decent journal passes such pseudoscience for publication as though it is serious science.
Yes, that would be nice!
You want to lose weight?
Just take a few pills an Bob’s your uncle!
There is, of course no shortage of such pills – but do they work?
This study aimed at quantifying and ranking the effects of different nutraceuticals on weight loss. PubMed, Scopus, and Web of Science to November 2022 were searched and all randomized trials (RCTs) evaluating the comparative effects of two or more nutraceuticals, or comparing a nutraceutical against a placebo for weight loss in adults with overweight or obesity were included. A random-effects network meta-analysis was conducted with a Frequentist framework to estimate mean difference [MD] and 95% confidence interval [CI] of the effect of nutraceuticals on weight loss.
One hundred and eleven RCTs with 6171 participants that investigated the effects of 18 nutraceuticals on body weight were eligible. In the main analysis incorporating all trials, there was high certainty of evidence for supplementation of spirulina (MD: -1.77 kg, 95% CI: -2.77, -0.78) and moderate certainty of evidence that supplementation of curcumin (MD: -0.82 kg, 95% CI: -1.33, -0.30), psyllium (MD: -3.70 kg, 95% CI: -5.18, -2.22), chitosan (MD: -1.70 kg, 95% CI: -2.62, -0.78), and Nigella sativa (MD: -2.09 kg, 95%CI: -2.92, -1.26) could result in a small improvement in body weight. Supplementations with green tea (MD: -1.25 kg, 95%CI: -1.68, -0.82) and glucomannan (MD: -1.36 kg, 95%CI: -2.17, -0.54) demonstrated small weight loss, also the certainty of evidence was rated low.
The authors concluded that supplementations with nutraceuticals can result in a small weight loss in adults with overweight or obesity.
The authors tell us little about the methodological quality of the studies. All they did report was this:
Among trials with a low risk of bias, only chitosan (mean difference: −1.72 kg, 95%CI: −3.37, −0.06) and green tea (mean difference: −1.61 kg, 95%CI: −3.14, −0.09) were effective for weight loss compared with placebo. There was no significant weight loss following increased consumption of other nutraceuticals in trials with a low risk of bias.
In view of the lack of reliability of the primary studies, I feel that the conclusions drawn by the authors are not justified. Even though far from recent, I much prefer our own conclusion of a similar data set:
The evidence for most dietary supplements as aids in reducing body weight is not convincing. None of the reviewed dietary supplements can be recommended for over-the-counter use.
In other words, if you want to lose weight, don’t rely on dietary supplements!
This systematic review and meta-analysis was aimed at analyzing the effectiveness of craniosacral therapy in improving pain and disability among patients with headache disorders.
PubMed, Physiotherapy Evidence Database, Scopus, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases were searched in March 2023. Two independent reviewers searched the databases and extracted data from randomized clinical trials comparing craniosacral therapy with control or sham interventions. The same reviewers assessed the methodological quality and the risk of bias using the PEDro scale and the Cochrane Collaboration tool, respectively. Grading of recommendations, assessment, development, and evaluations was used to rate the certainty of the evidence. Meta-analyses were conducted using random effects models using RevMan 5.4 software.
The searches retrieved 735 papers, and 4 studies were finally included. The craniosacral therapy provided statistically significant but clinically unimportant change on pain intensity (Mean difference = –1.10; 95% CI: –1.85, –0.35; I2: 44%), and no change on disability or headache effect (Standardized Mean Difference = –0.34; 95% CI –0.70, 0.01; I2: 26%). The certainty of the evidence was downgraded to very low.
The authors concluded that very low certainty of evidence suggests that craniosacral therapy produces clinically unimportant effects on pain intensity, whereas no significant effects were observed in disability or headache effect.
I find it strange that researchers seem so frequently unable to formulate their conclusions clearly. Is it political correctness? Or are they somehow favorably inclined (i.e. biased) towards the treatment that they pretend to critically evaluate?
Let’s look at the facts related to this review:
- Craniosacral therapy (CST) is utterly implausible.
- Only 4 RCTs were found.
- They were of poor quality.
- They were published mostly by people who want to promote CST.
- Therefore the overall statistically significant effect is most likely a false-positive result.
- This means that the conclusion should be much more straight forward.
I suggest something along the following lines:
A critical evaluation of the existing RCTs failed to find convincing evidence that CST is an effective treatment for headache disorders.
This randomised, double blind controlled trial compared the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
The interventions were:
- curcumin alone (C),
- omeprazole alone (O),
- curcumin plus omeprazole (C+O).
Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Main outcome measure was unctional dyspepsia symptoms on days 28 and 56, assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
A total of 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
The authors concluded that curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
This study, which was funded by the Thai Traditional and Alternative Medicine Fund, has been picked up by the press and is being lauded as a solid proof of efficacy. Its authors too are not half proud of their splendid trial:
This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia. PPIs, widely used and approved for over-the-counter use, were compared with curcumin, a popular herbal remedy. The study design, including double blind randomisation, minimised biases. Participants met strict criteria, underwent endoscopy and were tested for H pylori infection. Furthermore, we implemented measures to minimise biases by ensuring that the individuals administering the drugs, participants receiving the drugs and individuals conducting the assessment remained blinded to the type of medications administered to the participants. The trial was carried out in hospitals, and certified individuals used standardised questionnaires for assessments. Statistical methods were appropriate and followed accepted principles.
Two follow-up appointments were scheduled, and blood tests showed no abnormal symptoms or liver function abnormalities. However, participants with high body mass index indicated a trend towards liver function impairment in the curcumin group, suggesting the need for larger studies. Some participants did not provide follow-up information, which is a study weakness. However, the number of participants who provided this information was sufficient for statistical analysis and the majority of the participants attended the follow-up visit. Therefore, it can be deduced from the results that even if the number of participants followed after drug administration increased, the study findings would not be significantly different. Another limitation of this study was the absence of long term follow-up data for all patients after treatment. This is a question that will require further investigation.
The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects. The study was unbiased, partially funded by government organisations and the first well designed trial comparing curcumin with PPI for functional dyspepsia, with confirmation through endoscopy and ruling out H pylori infection. Limitations of this study included the small number of patients who were lost to follow-up and the lack of long term follow-up data.
However, I am far less impressed.
Why?
Curcumin is bright yellow and has a very distinct taste/smell. Even though curumin was given in capsules, patients can easily tell what they are taking. I therefore doubt that they were adequately blinded. In fact, the authors seem to agree when they state the following:
We observed that despite improvements in pain and non-pain scores, there was no significant improvement in the SODA satisfaction scores in the O and C+O groups (table 3). A possible explanation for this observation could be related to the taste and/or smell of curcumin, which might have caused reduced pleasantness for the participants while ingesting it. This potential discomfort could offset the improvements in pain and non-pain symptoms, leading to the non-significant change in satisfaction score. Further studies may be needed to explore this hypothesis as well as to improve the palatability of curcumin.
Sadly, the success of blinding (which under such circumstances should always be tested) was not reported and probably not even quantified. If many patients were de-blinded, it seems inevitable that their expectation influenced the results. In other words, the much-lauded effect of curcumin might just be due to placebo and curcumin might be entirely useless. Or, to put it bluntly, the trial was not nearly as good as many made it out to be.
PS
Sad to see that the reviewers of a reputable journal failed to pick up on this significant flaw.
The aim of this systematic review was to update the current level of evidence for spinal manipulation in influencing various biochemical markers in healthy and/or symptomatic population.
Various databases were searched (inception till May 2023) and fifteen trials (737 participants) that met the inclusion criteria were included in the review. Two authors independently screened, extracted and assessed the risk of bias in included studies. Outcome measure data were synthesized using standard mean differences and meta-analysis for the primary outcome (biochemical markers). The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used for assessing the quality of the body of evidence for each outcome of interest.
There was low-quality evidence that spinal manipulation influenced various biochemical markers (not pooled). There was low-quality evidence of significant difference that spinal manipulation is better (SMD -0.42, 95% CI – 0.74 to -0.1) than control in eliciting changes in cortisol levels immediately after intervention. Low-quality evidence further indicated (not pooled) that spinal manipulation can influence inflammatory markers such as interleukins levels post-intervention. There was also very low-quality evidence that spinal manipulation does not influence substance-P, neurotensin, oxytocin, orexin-A, testosterone and epinephrine/nor-epinephrine.
The authors concluded that spinal manipulation may influence inflammatory and cortisol post-intervention. However, the wider prediction intervals in most outcome measures point to the need for future research to clarify and establish the clinical relevance of these changes.
The majority of the studies were of low or very low quality. This means that the collective evidence is less than reliable. In turn, this means, I think, that the conclusions are misleading. A more honest conclusion would be this:
There is no reliable evidence that spinal manipulation influences inflammatory and cortisol levels.
As for the clinical relevance, I would like to point out that it would not be surprising if chiropractors could one day convincingly show that spinal manipulation do influence various biochemical markers. Many things do! If you fall down a staircase, for instance, plenty of biochemical markers will be affected. This, however, does not mean that throwing our patients down the stairs is of therapeutic value.
